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NEW QUESTION # 50
An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?
Answer: B
Explanation:
The Principal Investigator (PI) is responsible for conducting a root cause analysis when non-compliance is identified at the site. The PI must identify the reasons for non-compliance and develop a Corrective and Preventive Action (CAPA) plan to address and prevent future occurrences.
This answer aligns with GCP principles that designate the PI as responsible for site-level compliance and corrective actions.
"The PI must take responsibility for investigating the cause of non-compliance and developing a CAPA plan to mitigate recurrence." Objectives:
* Maintaining compliance and data integrity
* Addressing non-compliance proactively
NEW QUESTION # 51
A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?
Answer: B
Explanation:
The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial's integrity and data quality are compromised.
This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.
"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements." Objectives:
* Assessing resource availability
* Ensuring readiness to initiate a clinical trial
NEW QUESTION # 52
Which of the following is a conflict of interest for a PI conducting a study?
Answer: B
Explanation:
A Principal Investigator (PI) who is involved in voting on the IRB/IEC approval of their own protocol is considered to have a conflict of interest. The IRB/IEC must be independent and impartial when reviewing research proposals. Allowing the PI to vote on their own study compromises the ethical review process. To maintain unbiased decision-making, PIs must recuse themselves from such votes.
GCP guidelines emphasize the importance of avoiding conflicts of interest in the IRB/IEC decision-making process to maintain objectivity and ethical standards.
"A PI should not participate in voting or decision-making processes regarding the approval of their own study to avoid conflicts of interest." Objectives:
* Maintain impartiality in ethical review.
* Prevent conflicts of interest during IRB/IEC processes.
NEW QUESTION # 53
During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?
Answer: C
Explanation:
The Principal Investigator (PI) is responsible for ensuring that all equipment used in the clinical trial is properly maintained and serviced. If a monitor (CRA) identifies equipment that needs servicing, the PI must take immediate action to ensure the equipment is in working order to maintain the quality and integrity of the study data.
GCP guidelines emphasize the PI's responsibility to ensure that all equipment used in the study is functional, properly calibrated, and serviced as needed.
"The PI is responsible for maintaining the functionality and calibration of study-related equipment to ensure accurate data collection." Objectives:
Maintain equipment functionality to ensure data accuracy.
Ensure proper maintenance as part of site management.
NEW QUESTION # 54
A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?
Answer: C
Explanation:
Since both the investigator and the participant are unaware of the treatment assignment, the study is classified as double-blind. The study aims to establish the superiority of XYZ over ABC, making it a superiority study.
The use of masked IV bags confirms the double-blind design.
The answer is verified from GCP guidelines on blinding and superiority study designs.
"In double-blind studies, neither the participant nor the investigator knows the treatment assignment, which prevents bias." Objectives:
* Understanding blinding methods in clinical trials
* Ensuring unbiased efficacy comparisons
NEW QUESTION # 55
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